Senior Sterile Process Engineer - GMP/Validation

Resilience; Port Union (OH); On-site; USD 80,000 - 121,000; Full time

Benefits offered by this job

Annual bonus program

401(k) plan with company match

Healthcare including medical, dental &

Vision benefits

Paid vacation & holidays

Tuition reimbursement

Caregiving support

Job summary

Resilience is seeking a Process Engineer III, Sterile Operations to lead improvement initiatives across multiple sterile manufacturing processes and serve as the primary escalation point for complex technical issues. This role collaborates with Technical Operations, Quality, Manufacturing, and Facility teams to ensure validated, compliant, and efficient operations.

The successful candidate will bring GMP expertise, hands-on experience in aseptic environments, and a track record of coaching peers

Qualifications

• GMP experience in a sterile or aseptic manufacturing environment
• Hands-on experience across mechanical, hydraulic, pneumatic, vacuum, electronics, and control systems
• Ability to independently lead technical troubleshooting across multiple processes
• Experience coaching peers on GMP practices and process improvements
• Proven capability to manage complex investigations and deviations

Responsibilities

• Lead process and equipment improvement across multiple sterile manufacturing processes
• Develop and execute validation and transfer activities, including URS, FAT, SAT, IQ/OQ/PQ
• Author and review validation and change control documents and SOPs
• Provide escalation support for complex technical issues and train Operations/Engineering teams
• Drive continuous improvement in changeover, yield, OEE, and waste reduction

Skills

GMP experience

Technical troubleshooting

Leadership / coaching

Problem solving

Cross-functional collaboration

Education

Bachelor’s degree in Engineering or related science

Tools

Automation/controls

Aseptic fill-finish equipment

Sterile process/materials

Maintenance

Validation

Job description

Resilience is seeking a Process Engineer III, Sterile Operations to lead improvement initiatives across multiple sterile manufacturing processes and serve as the primary escalation point for complex technical issues. This role collaborates with Technical Operations, Quality, Manufacturing, and Facility teams to ensure validated, compliant, and efficient operations.

The successful candidate will bring GMP expertise, hands-on experience in aseptic environments, and a track record of coaching peers